← Product Code [HQC](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC) · K964018

# PHACOILLUMINATOR - FIBEROPTIC SLEEVE (K964018)

_Michael Reynard, M.D. · HQC · Feb 26, 1997 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K964018

## Device Facts

- **Applicant:** Michael Reynard, M.D.
- **Product Code:** [HQC](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC.md)
- **Decision Date:** Feb 26, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4670
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Intended Use

Provide illumination at surgical site.

## Device Story

Clear silicone sleeve; fits over phacofragmentation handpiece; transmits light from internal fiber optic channels to surgical site. Used in ophthalmic surgery by surgeons. Enhances visualization of surgical field during phacoemulsification; facilitates surgical precision.

## Clinical Evidence

Bench testing only.

## Technological Characteristics

Clear silicone material; sleeve form factor; passive light transmission via fiber optic coupling; non-powered; sterile.

## Regulatory Identification

A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

## Predicate Devices

- silicone infusion sleeve (unspecified)

## Submission Summary (Full Text)

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K964018

# CONFIDENTIAL AND PROPRIETARY INFORMATION

Page Three

510(k) Summary per section 807.92(c)

Submitter Name: Michael Reynard, M.D.
Address: 1301 - 20th Street #260, Santa Monica, CA 90404
Telephone: 310-453-0551    FAX: 310-315-0133
Contact Person: Michael Reynard, M.D.
Date of Summary: 9/30/1996

Name of Device: Accessory Illuminating Infusion Sleeve

Tradename of Device: Phacoilluminator™

Equivalence: The subject device is a predicate silicone infusion sleeve without opaque or tint additives.

Description of Device: Clear silicone sleeve that transmits light originating from fiber optic channels contained in the phacofragmentation handpiece.

Intended Use of Device: Provide illumination at surgical site.

Comparison with predicate devices: Construction material is identical with currently manufactured silicone infusion sleeve except that opaque additives are omitted to allow for light transmission.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K964018](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K964018)

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